FDA 510(k) Applications for Medical Device Product Code "OWW"

FDA 510(k) Number Applicant Device Name Decision Date
K160364 Alafair Biosciences Inc VersaWrap Tendon Protector 06/10/2016
K240817 Alafair Biosciences Inc. VersaWrap 06/14/2024
K222220 CelestRay Biotech Company, LLC SpinMedix Absorbable Fibrous Membrane 07/06/2023
K242187 CONMED Corporation BioBrace« 11/27/2024
K241906 CONMED Corporation BioBrace« Reinforced Implant 07/29/2024
K230316 International Life Sciences FlexBand; FlexPatch; FlexBand Plus 05/26/2023
K250021 Nanofiber Solutions, LLC Rotium 02/27/2025
K121216 SOFT TISSUE REGENERATION, INC. STR GRAFT 11/21/2012


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact